C. trachomatis is a gram-negative bacterium that refers to an obligate intracellular human pathogen. Chlamydia has two-phase cycle of development that consists of two forms of pathogen existence: extracellular elementary bodies and intracellular reticular bodies.
One of the most common bacterial STD in men and women is an urogenital infection (UGI) caused by C. trachomatis. 
There are over 20 nosological forms among diseases induced by C. trachomatis species where special role plays sexually transmitted urogenital Chlamydia infection (UGCI) affecting human urogenital tract. Urogenital Chlamydia infection—cervicitis, urethritis, proctitis, endometritis, salpingitis, perihepatitis—in women; urethritis, epididymitis, proctitis, prostatitis—in men—are most common among sexually active population.
Chlamydia are detected in 50-57% of sterility cases. There are observed not only functional disorders of reproduction, but also involvement of homeostasis control systems, immune competent cells etc. Chlamydia infections incidence in case of tubal infertility is from 41 to 54%. After first case of chlamydiosis the risk of tubal infertility increases by 10%, after third case—by 50%. In infertile couples 50-55% of men are sterile, and in 64% of these cases sterility is caused by UGCI. Chlamydia can cause infertility as a result of direct exposure on sperm due to tight adhesion of Chlamydia on male gametes that prevents impregnating the ovum. Some authors note that secondary female infertility in case of ascending UGCI is observed more often (in 6 times) than in case of gonorrhea.
C. trachomatis is observed in 9-30% of cases of ectopic pregnancy. In recent years has been noted increase of chlamydiosis of pregnant (10-40%) and newborns. In 40-60% of cases infected women transmit infection to newborns.
UGI's are diagnosed in 46% of cases at the age of 15-19 years old, and in 30% at the age of 20-24 years old. Incidence is quite high not only among adult population and teenagers having sexual relations but also among younger children without sexual relations. Thus, C. trachomatis has been observed in 67.4% of boys under 12 years old with UGI. In this case clinical picture of UGCI conformed to urethritis, and ultrasonography showed traces of past prostatitis in 7.9% of children.
It is very important that 75% of women and 40% of men had asymptomatic disease, and 30-40% of teenagers had latent Chlamydia infection proceeding from 2 to 5 years. Asymptomatic disease is typical not only for Urogenital localization, but also for infections of other organs. Epidemiological importance of asymptomatic Chlamydia infection was shown in works of A. Shatkin, the founder of Chlamydiology in Russia. Chlamydia isn't a member of normal human flora. Detection of it indicates infectious process, and the absence of clinical symptoms determines only temporary balance between a parasite and a host under conditions limiting but not inhibiting growth of intracellular pathogens. In this regard, Chlamydia infection with clinical asymptomatic course is dangerous as its manifest forms and needs treatment and prevention. Undiagnosed, untreated or improperly treated patients with acute, subacute or slow Chlamydia inflammatory processes are most attributable to incidence of infection nowadays.
In many developed countries of Europe and the US national UGCI control programs based on screening of high-risk population, early treatment, examination and treatment of partners have been realized for over 25 years. Despite these actions, cases of primary chlamydiosis and reinfection have still increased.
During recent years incidence of urogenital Chlamydia infections in the Russian Federation has come out on top among all the sexually transmitted bacterial infections and it gives way only to trichomoniasis.
According to Central Scientific and Research Institute for Organization and Information Support of Health Care FSU, UGCI incidence comparing to 1994 increased in 1.7 times (61.4 versus 101.7). In 2005, total number of STD cases amounted to 503.6 per 100000 of population, in 2006—decreased to 4.1%. However, UGCI in 2005 amounted to 95.9 per 100000 (adults) and 3.1 per 100000 (children); in 2006—97.2 per 100000; in 2007—91.1 per 100000 (adults) and 3.2 per 100000 (children).
In 2008, 611634 cases of sexually transmitted infections were registered, that amounted to 403.5 per 100000 of population. Chlamydia infection amounted to 20.8%. For the last 3 years reduction of patients with STD (including 8.4% with chlamydia infection) is observed all over the Russia. Incidence of Chlamydia infection in Russia in 2008 was 89.5 per 1000000 of adult population and 2.8 per 100000 of children.
So medical and social role of Chlamydia infection is firstly caused by high incidence and frequent complications, and also by effect on demographic determinants due to fact that UGCI is the most frequent cause of female and male infertility.
Urogenital chlamydiosis therapy represents the most difficult aspect of the concerned issue, which is associated not only with features of infectious agent and its development cycle but also with association of chlamydiosis with other infection in 70% of cases: ureaplasma, herpes simplex virus, Gardnerella vaginalis etc. Causal treatment is based on chlamydial antibiotics susceptibility. Widespread use of tetracycline antibiotics in treatment of chlamydiosis (doxycycline, metacycline, minocycline, and tetracycline) is quite reasonable. According to WHO recommendations: 100 mg doxycycline orally twice a day or 500 mg tetracycline orally 4 times a day, course of treatment—7 days. It must be noted that number of ineffective treatment cases has significantly increased recently, which, probably, may be due to resistance of causative agent to antibiotic in population. Doses and treatment duration must be adjusted evidently depending on UGCI course (acute, chronic, ascending infection, exacerbation etc.). The most conflicts of researchers are related to use of fluroquinolone antibiotics: ofloxacin, pefloxacin, ciprofloxacin. Some authors report efficient ofloxacin therapy in 81-100% of cases (200-300 mg per os twice a day during 7 days); others report high failure rate and the worst long-term outcomes. Treatment of chronic, complicated forms of chlamydiosis currently presents very serious and unresolved problem. This is firstly related to fact that during chronization of infectious process in macroorganism occur persisting forms of Chlamydia that are antibiotic-resistant and are adjusted to long term survival. That is why treatment of chronic forms of UGCI with antibiotics, according to numerous clinical and microbiological studies, is inefficient. The situation makes development of new antibacterial products, mechanism of action of which shall be fundamentally different comparing to antibiotic action, very important.
Murine monoclonal antibodies specific to major outer membrane protein (MOMP) of C. trachomatis, can act as the closest technical decision analog, making the ground of the present invention. Antibodies were prepared by standard method of isolation of monoclonal antibodies based on hybridome technology with mice immunization. Isolated antibodies recognized MOMP of C. trachomatis, identifying epitopes, localized at the surface of Chlamydia cell. Antibodies reduced toxicity of causative agent in mice in vivo.
Zhang, Y.-X., S. J. Stewart, and H. D. Caldwell. Protective monoclonal antibodies to Chlamydia trachomatis serovar- and serogroup-specific major outer membrane protein determinants. Infect. Immun. 1989, 57:636-638 (SUPPLEMENT 1)
This technical decision as the closest to the claimed one regarding active ingredient composition and mode of its use has been chosen by the authors of this invention as a prototype.
The disadvantages of the prototype are:
1) Relatively expensive production of antibodies, difficulties in maintaining and storage of the producer, extremely high requirements to quality of the used reagents and culture conditions.
2) Relatively large size of isolated antibodies resulting in low tissue permeability.
3) Structural characteristics impose restrictions on recognition of some “hidden” epitopes located, in clefts, fissures of small size in protein structures.
4) Limitation and relative complexity of genetic engineering manipulations, adaptations for specific issues, difficulties in creation of multivalent and multifunctional derivatives of specified antibodies.
Thus, there is a need in development of new antibodies—antigen-recognizing molecules without any of the said disadvantages and specifically recognizing C. trachomatis, in the technical level.